Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05630950

LDCT-SC-FI Low-dose CT Screening for Lung Cancer

This is a randomized phase II trial investigating different smoking cessation methods in study subjects undergoing lung cancer screening with low-dose CT (LDCT). The study also evaluates feasibility and outcomes of LDCT screening and potential biomarkers and AI-based evaluation on CT-scans. The study subjects fulfilling I/E-criteria are randomized in 1:1 fashion to yearly LDCT for two rounds with standard smoking cessation (control) or same LDCT approach combined to mobile application based smoking cessation (intervention).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Lung Cancer Screening

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital, Oulu, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to provide written informed consent
  • Age between 50-74
  • Smoked ≥ 15 cigarettes/day for ≥ 25 years or smoked ≥ 10 cigarettes/day for ≥ 30 years and are active smokers (smoking during the last two weeks)
  • Access to a smartphone (iPhone or Android)

Exclusion criteria

  • A moderate or bad self-reported health; e.g. unable to climb two flights of stairs
  • Body weight ≥ 140 kilogram
  • Current or past melanoma, lung, renal or breast cancer
  • A chest CT examination less than one year before inclusion
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Subject is unwilling or unable to comply with treatment and trial instructions
  • Any condition that study investigators consider an impediment to safe trial participation

Treatment and study plan

Smoking cessation mobile application

Device

Mobile application for smoking cessation.

Written material for smoking cessation

Behavioral

Written material for smoking cessation

Primary outcomes

  1. Number of active smokers at 3 months

    Time frame: 3 months

    The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms

Secondary outcomes

  1. Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months

    Time frame: 3 months

    The percentage of subjects who have reduced the amount of smoked cigrattes/d at 3 months after inclusion compared to between the study arms

  2. Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months

    Time frame: 6 months

    The percentage of subjects who have reduced the amount of smoked cigrattes/d at 6 months after inclusion compared to baseline between the study arms

  3. The reduction in number of smoked cigarettes/d at 3 months

    Time frame: 3 months

    Magnitude of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms.

  4. The reduction in number of smoked cigarettes/d at 6 months

    Time frame: 6 months

    Magnitude of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms.

  5. The percentage of reduction in number of smoked cigarettes/d at 3 months

    Time frame: 3 months

    Percentage of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms.

  6. The percentage of reduction in number of smoked cigarettes/d at 6 months

    Time frame: 6 months

    Percentage of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms.

  7. Sensitivity of CT screening in the whole cohort

    Time frame: At 2 years

    The amount of true positive CT scans for lung cancer compared to false negative CT scans for lung cancer.

  8. Costs related to CT screening including additional investigations

    Time frame: At 2 years

    The cumulative cost of diagnostic investigations per study subject.

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Registry information

Official study title

Low-dose CT Screening for Lung Cancer Combined to Different Smoking Cessation Methods in Finland

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 30, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.